Laryngeal transplantation
Conditions
Interventions
Test Group:Laryngal-tracheal transplantation was performed after total laryngectomy
Control Group:Total Laryngectomy alone (within the same period of time)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for Test group: To be eligible for the study, participants had to meet the following criteria at the same time: a. Study participants who underwent total laryngectomy due to a variety of causes (including but not limited to advanced laryngeal cancer, laryngeal cancer recurrence, hypopharyngeal and cervical esophageal cancer, tongue cancer, trauma, postoperative recurrence of advanced thyroid cancer, etc.); b. Study participants under 75 years old (including 75 years old) with urgent needs for voice function; c. Study participants with good general condition or combined with hypertension, diabetes, coronary heart disease, thyroid dysfunction, liver and kidney dysfunction and other basic diseases who were feasible for surgery after multidisciplinary consultation evaluation; d. Participants who are willing to take life-long immunosuppressive drugs and the risks involved or who have previously required life-long immunosuppressive drugs for other causes (e.g., other organ transplantation, certain rheumatic diseases, etc.); e. Study participants and their family members (main accompany) have certain language, reading, writing and communication skills to facilitate the completion of the questionnaire; f. Voluntarily participated in this study after informed consent, agreed to undergo laryngal-tracheal transplantation, and could return to the hospital on time for follow-up. 2. Inclusion criteria for Control group: To be eligible for the study, participants had to meet the following criteria at the same time: a. Study participants who required total laryngectomy for a variety of causes (including but not limited to advanced laryngeal cancer, laryngeal cancer recurrence, hypopharyngeal and cervical esophageal cancer, tongue cancer, trauma, postoperative recurrence of advanced thyroid cancer, etc).; b. Under the age of 75 years old (including 75 years old); c. The study participants and their family members (the main accompany) have certain language, reading, writing and communication skills to facilitate the filling of the questionnaire; d. Voluntarily participated in this study after informed consent, agreed to undergo total laryngectomy, and could return to the hospital on time for follow-up.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria for Test group: Study participants were ineligible if they met any of the following criteria: a. Over 75 years old of age, no urgent need for laryngeal function such as voice function; b. Poor general condition, unable to tolerate laryngotracheal transplantation and lifelong immunosuppressive therapy; c. Patients are still living with tumor after total laryngectomy (including but not limited to local recurrence, distant metastasis, and new tumors in other sites); d. Patients with psychiatric or psychological disorders prior to total laryngectomy. 2. Exclusion criteria for Control group: Study participants were ineligible if they met any of the following criteria: a. older than 75 years old of age; b. Patients are still living with tumor after total laryngectomy (including but not limited to local recurrence, distant metastasis, and new malignant tumors in other sites); c. Patients with psychiatric or psychological disorders prior to total laryngectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival;Rrecovery time of Voice function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Free Survival;Graft Survival;Postoperative adverse event incidence rate;Quality of Survival (European five-dimensional Health Scale score,Anderson Symptom Assessment Scale( Head and Neck) score, etc.);Psychological State (Self-rating Anxiety Scale score, Self-rating Depression Scale score, etc.);Primary Caregiver Psychological Status (Sense of Coherence);Recovery time of Swallowing function;Rate of olfactory change; | — |
Countries
China
Contacts
Public ContactChen Fei
West China Hospital, Sichuan University
Outcome results
None listed